<Trial identifier> Version Control Log Purpose To ensure appropriate trial oversight, it is important to keep track of the essential documents used for the trial, and their latest approved version. Overviews must be provided to those performing quality checks at sites, e.g. on-site monitoring. This template can be used for this purpose. Initial Document Version (first used by Site) Document Title/ID Document Title/ID Document Title/ID Document Title/ID Document Title/ID Document Title/ID (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) Version Number and Date Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (1): Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (2): Date of Regulatory Approvali Date of NHS Approvalii i Including REC, MHRA etc.: either list last approval date or ‘N/A’ if not required ii Either list date, have Site list date or enter ‘Not required’ Document1 File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files. Update to Page ____ of ____ ; here Page 1 of 4 <Trial identifier> Version Control Log Document Title/ID Document Title/ID Document Title/ID Document Title/ID Document Title/ID Document Title/ID (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) Version Number and Date Amendment Ref (3): Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (4): Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (5): Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (6): Date of Regulatory Approvali Date of NHS Approvalii i Including REC, MHRA etc.: either list last approval date or ‘N/A’ if not required ii Either list date, have Site list date or enter ‘Not required’ Document1 File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files. Update to Page ____ of ____ ; here Page 2 of 4 <Trial identifier> Version Control Log Document Title/ID Document Title/ID Document Title/ID Document Title/ID Document Title/ID Document Title/ID (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) (e.g. protocol, consent form) Version Number and Date Amendment Ref (7): Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (8): Date of Regulatory Approvali Date of NHS Approvalii Version Number and Date Amendment Ref (9): Date of Regulatory Approvali Date of NHS Approvalii Acknowledgements We would like to acknowledge the Wellcome Trust Clinical Research Facility at University Hospital Birmingham for sharing the first version of this template i Including REC, MHRA etc.: either list last approval date or ‘N/A’ if not required ii Either list date, have Site list date or enter ‘Not required’ Document1 File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files. Update to Page ____ of ____ ; here Page 3 of 4 <Trial identifier> i Including REC, MHRA etc.: either list last approval date or ‘N/A’ if not required ii Either list date, have Site list date or enter ‘Not required’ Document1 File original in the Trial Master File, and forward copies of updated / completed Logs to the participating sites for their files. Version Control Log Update to Page ____ of ____ ; here Page 4 of 4